|Argos Announces Completion of Patient Enrollment in Pivotal Phase 3 ADAPT of AGS-003; Ocata Receives New U.S. Patent for Its RPE Therapy|
|By William Kent|
|Wednesday, 15 July 2015 19:16|
Below is a look at some of the headlines for companies that made news in the healthcare sector on July 15, 2015.
Argos Therapeutics Inc. (NASDAQ: ARGS) announced the pivotal phase 3 ADAPT clinical trial of AGS-003 in combination with standard targeted therapy for the treatment of metastatic renal cell carcinoma (mRCC) has reached its enrollment goal of at least 450 randomized patients.
"Strong partnerships and coordination across our global study base to identify eligible patients and collect tumor samples have led to successful enrollment for the largest clinical trial ever conducted in patients with newly diagnosed, unfavorable risk, synchronous metastatic RCC," said ADAPT trial co-principal investigator and lead medical oncologist Dr. Robert Figlin, the Steven Spielberg Family chair in hematology oncology and professor of medicine and biomedical sciences at the Cedars-Sinai Samuel Oschin Comprehensive Cancer Institute. "With enough patients screened with successful tumor collection to meet and exceed our target of 450 randomized patients, we look forward to shifting our full attention to the treatment phase of the study and expected data readouts in 2016."
AGS-003 is an autologous dendritic-cell based immunotherapy designed to induce a memory T-cell response specific to each patient's unique tumor antigens. It is produced using a small sample from a patient's own tumor and dendritic cells derived from a leukapheresis procedure. In an open-label phase 2 study, treatment with AGS-003 plus sunitinib yielded a median overall survival of more than 30 months in newly diagnosed, unfavorable risk mRCC patients.
To qualify for the ADAPT trial, patients were required to be good candidates for standard surgery and targeted drug therapy. During the enrollment process approximately 55 percent of patients who consented for tumor collection and screening for the treatment phase of the trial were found to be ineligible for treatment because of non-clear cell histology, lack of suitability to initiate standard targeted drug therapy, poor performance status, poor prognosis after surgery, a lack of evaluable metastatic disease, or other factors.
"By concluding enrollment in the ADAPT trial, we have reached an exciting milestone by demonstrating the ability to rapidly screen and collect tumor samples for more than 1,000 newly diagnosed metastatic RCC patients over the course of approximately two years," said ADAPT trial co-principal investigator and lead urologic oncologist Dr. Christopher Wood, professor of urology and deputy chairman of the department of urology, division of surgery at the University of Texas MD Anderson Cancer Center. "This would not have been possible without a strong multidisciplinary collaboration among urologists and oncologists, which positions us well to advance our evaluation of AGS-003 in addition to standard treatment through trial completion."
"The ADAPT trial is focused on a population with significant unmet needs as the expected median survival based upon International mRCC Database Consortium (IMDC) benchmarks is approximately 15 months after diagnosis, even with standard surgery and approved targeted therapies," said Doug Plessinger, vice president of clinical and medical affairs for Argos Therapeutics. "We continue to believe that the combination of standard treatment with our personalized immunotherapy has the potential to bring new hope to mRCC patients, and we look forward to the next interim data review from the ADAPT trial in the first part of 2016."
Ocata Therapeutics, Inc. (NASDAQ: OCAT), announced that it continues to fortify the patent protection covering its retinal pigment epithelium (RPE) transplant technology for macular degeneration with the issuance by the United States Patent and Trademark Office (USPTO) of U.S. Patent No 9,080,150.
"The issuance of this 9th U.S. patent in our global RPE portfolio represents yet another example of the leadership position we have established as pioneers in Regenerative Ophthalmology," said Paul K. Wotton, Ph.D., President and Chief Executive Officer. "In particular, this new patent provides coverage for the manufacture of all RPE products from any pluripotent source by defining the basic universal markers of RPE essential for therapeutic use. We have recently received patent protection for the manufacture of human RPE cell products from pluripotent stem cell sources, including manufacture of formulation forms for use as therapeutic agents as well as the use of these RPE formulations for treating degenerative ophthalmic diseases, such as dry age-related macular degeneration (dry AMD) and Stargardt's macular degeneration (SMD)."
AB Science SA (NYSE Euronext - FR0010557264 - AB), a pharmaceutical company specialized in research, development and marketing of protein kinase inhibitors (PKIs), announces the initiation of a seamless adaptive design phase 2/3 study to evaluate the safety and efficacy of masitinib in combination with gemcitabine in patients with refractory advanced or metastatic epithelial ovarian cancer.
Amarantus BioScience Holdings, Inc. (OTCQX:AMBS), a biotechnology company focused on developing therapeutic and diagnostic products for diseases in the areas of neurology, psychiatry, ophthalmology and regenerative medicine, announced that it has completed the acquisition of Cutanogen Corporation ("Cutanogen") from Lonza Walkersville, Inc. ("Lonza"), a subsidiary of Lonza Group Ltd. Cutanogen has an exclusive worldwide license to intellectual property rights associated with Engineered Skin Substitute ("ESS"), an autologous full thickness skin replacement product in development for the treatment of severe burns.
Argos Therapeutics Inc. (Nasdaq:ARGS), an immuno-oncology company focused on the development and commercialization of fully personalized immunotherapies for the treatment of cancer based on the Arcelis® technology platform, today announced the pivotal phase 3 ADAPT clinical trial of AGS-003 in combination with standard targeted therapy for the treatment of metastatic renal cell carcinoma (mRCC) has reached its enrollment goal of at least 450 randomized patients.
Atara Biotherapeutics, Inc. (Nasdaq:ATRA), a biopharmaceutical company with a focus on developing innovative therapies for patients with debilitating diseases, today announced the closing of its underwritten public offering of 3,980,768 shares of its common stock at a public offering price of $52.00 per share, which included 519,230 shares sold pursuant to the full exercise by the underwriters of their option to purchase additional shares.
BG Medicine, Inc. (Nasdaq:BGMD), the developer of the BGM Galectin-3® Test, announced today that it has paid off its secured term loan facility with General Electric Capital Corporation and Comerica Bank.
CytoDyn Inc. (OTCQB:CYDY), a biotechnology company focused on the development of new therapies for combating human immunodeficiency virus (HIV) infection, today announced that its ongoing extension study of PRO 140 monotherapy in HIV-infected patients has shown complete viral-load suppression for nearly 11 months.
Fate Therapeutics, Inc. (NASDAQ:FATE), a biopharmaceutical company engaged in the development of programmed cellular therapeutics for the treatment of severe, life-threatening diseases, announced today that it has named Dr. Stewart Abbot as Vice President, Translational Research, effective immediately.
FutureWorld Corporation (OTC: FWDG), the leading provider of advanced solutions to the cannabis industry globally, today announced that it has been selected by The Marijuana Index for inclusion in its MJIC US Reporting Index and Composite Global Index.
Hemispherx Biopharma, Inc. (NYSE MKT:HEB) announces that they have submitted an application for orphan drug designation to the European Medicines Agency (EMA) for Alferon N Injection®, an experimental therapeutic, to treat Middle East Respiratory Syndrome (MERS).
Histogenics Corporation (Nasdaq:HSGX), a regenerative medicine company focused on developing and commercializing products in the musculoskeletal space, announced the appointment of Dr. Gloria Matthews, DVM, Ph.D., DAVCS, as its Chief Medical Officer.
Integra LifeSciences Holdings Corporation (NASDAQ:IART) will release its second quarter 2015 financial results on Thursday, July 30, 2015.
Medgenics, Inc. (NYSE:MDGN), the developer of a proprietary platform for the sustained production and delivery of therapeutic proteins and peptides in patients using ex vivo gene therapy and their own tissue for the treatment of rare and orphan diseases, today announced that the first patient has been enrolled in its U.S.-based Phase 2 clinical trial of MDGN-201 (TARGTEPOTM), an investigational gene therapy for the treatment of anemia in end stage renal disease (ESRD) patients undergoing peritoneal dialysis.
RedHill Biopharma Ltd. (NASDAQ:RDHL) (TASE:RDHL), an Israeli biopharmaceutical company focused on late clinical-stage, proprietary, orally-administered, small molecule drugs for inflammatory and gastrointestinal diseases, including gastrointestinal cancers, today reported that it has elected to extend its August 2014 exclusive option agreement with RESprotect GmbH, a privately-held German-based biotech company for the acquisition of the oncology drug candidate RP101.
Rockwell Medical, Inc. (NASDAQ:RMTI), a fully-integrated biopharmaceutical company targeting end-stage renal disease (ESRD) and chronic kidney disease (CKD) with innovative products and services for the treatment of iron replacement, secondary hyperparathyroidism and hemodialysis, announced today the publication of the Triferic Phase 3 CRUISE studies (CRUISE 1 and 2) in Nephrology Dialysis Transplantation (NDT).
RedHill Biopharma Ltd. (NASDAQ:RDHL) (TASE:RDHL), an Israeli biopharmaceutical company primarily focused on late clinical-stage, proprietary, orally-administered, small molecule drugs for inflammatory and gastrointestinal diseases, including gastrointestinal cancers, today announced that it intends to offer up to 1.8 million of its American Depository Shares ("ADSs"), each representing ten of its ordinary shares, as part of its previously announced underwritten public offering.
XBiotech Inc., (NASDAQ:XBIT), the world's leading developer of next-generation True Human™ therapeutic antibodies, will host its inaugural quarterly business update conference call and live webcast on July 28, 2015, at 8:30am Eastern Time.